Kornimate/medical-research-clean huggingface dataset:
rheopheresis as adjuvant treatment of calciphylaxis

Conditions: Metabolic Disorder; End Stage Renal Disease; Rare Diseases

Summary: we propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population.

calciphylaxis, also known as uremic calcifying arteriolopathy (uca), is a rare disease that causes painful ischemic skin lesions due to microvascular calcification and thrombosis of the dermis and subcutaneous adipose tissue. patients with end-stage renal disease (esrd) are the main target for calciphylaxis. rheopheresis is a therapeutic apheresis to treat microcirculatory disorders. this double filtration plasmapheresis eliminates a defined spectrum of high molecular weight proteins from human plasma including relevant factors for vascular inflammation and thrombose. we propose a prospective randomized controlled trial to compared the efficacy of rheopheresis as adjuvant treatment to the standard of care compared to standard care with sham-apheresis.

Eligibility criteria:
inclusion criteria: * calciphylaxis with at least one ulcerated or necrotizing lesion * end stage renal disease requiring hemodialysis * weight superior to 30kg * subject affiliated to or beneficiary of a social security system * subject having signed written informed consent a patient with progressing calciphylaxis to ulcerate or necrosis despite conventional treatment may also be included. exclusion criteria: * karnofsky performance status scale inferior to 30% * life expectancy (independently of calciphylaxis) estimated \< 6 months according to a referring physician expert in hemodialysis * uncontrolled infection (persistence of fever despite appropriate antibiotic therapy) * common variable immunodeficiency * albumin allergy * contra-indication to stop anti-vitamin k treatment * severe cognitive or psychiatric disorders, patients unable to give an informed consent or unwilling to participate in the study * pregnancy or breastfeeding and all the other categories of people with special protection according to the french code de la santé publique (csp): patients under legal supervision, patients hospitalized without contentment, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations.

Keywords: calciphylaxis rheopheresis hemodialysis chronic kidney disease
fresh versus old red blood cells for transfusion

Conditions: Iron, Abnormal Blood Level; Other Abnormal Blood Chemistry

Summary: packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on food and drug administration (fda) guidelines. recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. the investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. the investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.

participants in this study will be asked to participate in a standard blood donation. the blood will be processed per standards at the investigators regional blood center (new york blood center) and then split into two equal units and shipped to columbia university medical center for storage and transfusion. one unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). the other unit will be transfused 42 days after donation. blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.

Eligibility criteria:
inclusion criteria: * healthy * male body weight \>130 lbs, female body weight \> 155 lbs * male height \>5'1", female height \>5'5" * hemoglobin \>13.3 g/dl exclusion criteria: * ineligible for donation based on the new york blood center autologous blood donor questionnaire * systolic blood pressure \>180 or \<90 mm hg * diastolic blood pressure \>100 or \<50 mm hg * heart rate \ 100 * temperature \>99.5 f prior to donation * temperature \>100.4 f or subjective feeling of illness prior to transfusion * positive results on standard blood donor infectious disease testing * pregnancy.

Keywords: red blood cells transfusion storage sickle cell disease β-thalassemia hemoglobin-associated iron
pilot study differential dissector™ for blunt dissection

Conditions: Surgical Adhesions; Blood Loss, Surgical

Summary: the primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.


Eligibility criteria:
inclusion criteria: * age greater than 18 * patient will be undergoing open abdominal surgery * patient willing and able to provide his/her own consent exclusion criteria: * current alcohol or other substance abuse * current incarceration

Keywords: abdominal surgery pelvic surgery stoma takedown bowel resection lysis of abdominal adhesions
sepsis in icu:causes and outcomes of sepsis in diabetics versus non diabetics in assiut university hospital

Conditions: Sepsis; Septic Shock

Summary: clarify different causes of sepsis in patients admitted to icu . as well ascompare causes and outcomes of sepsis between diabetics versus non diabetics . 3.screening for the commonest organism causing sepsis in critically ill patients. determine better protocol therapy that help in decreasing mortality and morbidity in patients with sepsis in icu.

sepsis is a physiologic, pathologic, and biochemical abnormalities induced by infection. sepsis is considered as a leading cause of mortality and critical illness worldwide by many conservative estimates. sepsis epidemiology studies worldwide revealed a highly variable incidence of 13-300 per 100,000 inhabitants per year for severe sepsis and 11 per 100,000 inhabitants per year for septic shock . factors such as advancing age, immunosuppression and multi-drug-resistant infection play a role in increasing incidence of sepsis during recent decades . patients who survive sepsis often have long-term physical, psychological, and cognitive disabilities with significant health and social implications. patients with diabetes mellitus have an increased risk of developing infections and sepsis and they constitute 20.1-22.7% of all sepsis patients. infection also remains an important cause of death in diabetics. the prevalence of diabetes mellitus in intensive care unit patients is as high as 30%, and such patients are at increased risk of experiencing in-hospital complications, compared to patients without diabetes. infective complications may be reduced with lower blood glucose concentrations moreover, in critically ill patients without diabetes, hyperglycemia is associated with increased mortality, risk of infection, kidney injury and cardiovascular complications. moreover, diabetes is a major risk factor for both acute kidney injury and sepsis. sepsis also is a major cause of acute kidney injury, which develops in one-fourth of all patients with sepsis and half of patients with bacteremia or shock . sepsis-related acute kidney injury is associated with high mortality rates of up to 70%.

Eligibility criteria:
inclusion criteria: patients admitted to icu for any reason and devoloped sepsis either on admission or later during thier hospital stay. patients having criteria of sepsis or septic shock as defined by 3rd consensus guidelines (sepsis 3) ,2016 exclusion criteria: previous history of pulmonary problem . previous history of cardiac disease. previous history of autoimmune disease immunocompromised patients
extension study of protocol enb-002-08 - study of asfotase alfa in infants and young children with hypophosphatasia (hpp)

Conditions: Hypophosphatasia

Summary: this clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset hpp who completed study enb-002-08 (nct00744042). partial funding for this study was provided by the office of orphan product development (oopd).

asfotase alfa was formerly referred to as enb-0040 hypophosphatasia (hpp) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. there are limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility criteria:
inclusion criteria * patient completed participation in enb-002-08 (nct00744042) * written informed consent by parent or other legal guardian prior to any study procedures being performed * parent or other legal guardian willing to comply with study requirements exclusion criteria * history of sensitivity to any of the constituents of the study drug * clinically significant disease that precludes study participation * enrollment in any study (other than enb-002-08) involving an investigational drug, device, or treatment for hpp (e.g., bone marrow transplantation)

Keywords: hypophosphatasia hpp bone disease soft bones low alkaline phosphatase genetic metabolic disorder alkaline phosphatase tissue non-specific alkaline phosphatase rickets osteomalacia
comparison of the effectiveness of fluidized positioner and memory foam pillow in the prevention of pressure injury in the children's head

Conditions: Pressure Injury

Summary: this study aims to compare the effectiveness of fluidized positioners and memory foam pillows in preventing pressure injuries in the head among pediatric patients. h1: there is a significant difference between the fluidized positioner and the memory foam pillow in terms of pressure injury incidence in pediatric intensive care patients. h2: the fluidized positioner reduces the risk of developing pressure injuries more effectively than the memory foam pillow. h3: there is a significant difference in the pressure applied to the head region of the patient between the fluidized positioner and the memory foam pillow. h4: the anatomical locations of pressure injuries (occipital, parietal, temporal, and ear regions) vary depending on the type of pillow used. h5: compared to the memory foam pillow, the fluidized positioner provides a more evenly distributed pressure across the occipital, parietal, temporal, and ear regions and prevents pressure concentration in specific areas.


Eligibility criteria:
inclusion criteria: * being treated in the pediatric intensive care unit * being mechanically ventilated * being immobile, being in age interval of 28 days to 5 years * having consent for the participation of the study exclusion criteria: * having surgical intervention in the head region * parents want to leave at any stage of the project * having hydrocephalus or burn in the head area * having pis on admission to hospital * existing dermatologic diseases affecting the skin or connective tissue * having emergence of a new condition during the intervention may significantly affect the risk of pressure injury (e.g., sudden surgery or complication) * inability to obtain sufficient data during the study (e.g., patient transfer)

Keywords: pediatric patients pressure injury risk assessment foam pillow fluidized positioner
an algorithm for predicting blood loss and transfusion risk in fast track total hip arthroplasty

Conditions: Total Hip Replacement; Blood Loss

Summary: aim of these study is to create an algorithm, using data from patients that undergoing total hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.

two different cohorts of patients undergoing total hip arthroplasty will be analyzed to obtain data about hemoglobin trends. the first group will be used to obtain the algorithm, the second one to validate results of the first group, determining sensitivity and specificity.

Eligibility criteria:
inclusion criteria: * patients with hip arthritis exclusion criteria: * asa 4 - 5 * active treatment with warfarin * coagulation disorders
can biomarkers aid in the prediction of postoperative pain and circulatory instability after major abdominal surgery?

Conditions: Systemic Inflammatory Response Syndrome

Summary: patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (sirs).this activation of the inflammatory system may induce instability of the heart and respiration in the postoperative period. the degree of physiologic response to postoperative sirs as well as the degree of postoperative pain differ between patients. therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia care unit' (pacu) after end of surgery.admittance to a pacu is expensive. the time patients need to stay in a pacu after major surgery has not been extensively studied, and more appropriate tools for prediction of length of stay are needed. the main aim of this study is to assess whether clinical observations, inflammatory biomarkers or genetic markers may aid in the prediction of physiological instability and/or pain after major surgery. such predictors would help clinicians planning the length of pacu-stays.


Eligibility criteria:
inclusion criteria: * patients undergoing major abdominal surgery (e.g. whipple's operation, liver resection, abdominoperineal resection, vascular abdominal surgery etc.) * scheduled for pacu stay first 24 hours exclusion criteria: * pregnancy * jehovah's witness * dementia

Keywords: abdomen/surgery biological markers length of stay postoperative care anesthesia recovery period prognosis
predicting hypotension during dialysis in the icu

Conditions: Peridialytic Hypotension

Summary: currently, decisions regarding volume management for dialysis sessions in the icu are made in large part on the nephrologists'/intensivists' overall gestalt. this gestalt is based upon a combination of commonly used measures of circulatory function, the physical exam, fluid balance, estimates of dialysis dry weight, and monitoring changes in relative blood volume status using devices such as the crit-line™ iii, and central venous pressures. however, these tools perform poorly in predicting the circulatory system's overall response to dialysis. consequently, episodes of dangerously low blood pressure are still frequently encountered. better techniques to predict the circulatory system's response to dialysis are much needed. the intent of this study is to test newer metrics of circulatory system function for their ability to predict low blood pressure episodes during dialysis. this is important because it may enable the design of newer treatment strategies created to prevent low blood pressure episodes during dialysis and improve patient outcomes. the investigators overall hypothesis is that newer measures of vascular volume and dynamic indices of fluid responsiveness, previously found to better reflect cardiac preload state than currently used parameters, will better predict low blood pressure episodes during dialysis than current methods.


Eligibility criteria:
inclusion criteria: * admitted to ohsu hospitals icus * patient has acute or chronic needs for intermittent hemodialysis support during their icu stay for any reason other than isolated hyperkalemia * central venous access in place separate from the dialysis catheter, or arteriovenous fistula or graft * two or more organ systems affected by critical illness requiring supportive care as documented in the medical chart. exclusion criteria: * age younger than 18 years old * weight \> 160 kg * burns greater than 40% total body surface area * known cardiac or vascular aneurysm * contraindications to femoral arterial puncture * diagnosis of peripheral vascular disease * not committed to full support * participation in other experimental medication trial within 30 days * current atrial or ventricular arrhythmias * history of sever chf- nyha class \>= iii, previously documented ef \< 30% * severe aortic regurgitation * anticipated icu stay \< 24 hrs * not expected to require dialysis \> 48 hours

Keywords: hemodialysis dialysis hypotension critline picco thermodilution cvvhdf ihd
women's knowledges about gynaecological aftercare

Conditions: Gynecology

Summary: the hypothesis of the investigators is that women don't have all the needfull knowledge to understand the importance of a regular gynaecological aftercare. the main objective is to assess women's knowledge's about gynaecological aftercare. the second objective is to identify barriers that prevent women of a regular gynaecological aftercare


Eligibility criteria:
inclusion criteria: * women aged over eighteen years old * women who are able to read and write french exclusion criteria: * women aged under eighteen years old * women who aren't able to read or write french

Keywords: gynaecological aftercare contraception breast cancer cervix cancer cervical screening breast self examination mammography midwife body knowledge prevention self care
arginase inhibition and microvascular endothelial function in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the present project is designed to test the hypothesis that arginase contributes to microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular complications.

background the development of microvascular complications in diabetes is a complex process, in which endothelial dysfunction is of importance. emerging evidence suggests that arginase is a key mediator of endothelial dysfunction in type 2 diabetes mellitus (t2dm) by reciprocally regulating nitric oxide bioavailability. the aim of this study was to test the hypothesis that arginase activity is increased and that arginase contributes to microvascular endothelial function in patients with t2dm and microvascular dysfunction. method microvascular endothelium-dependent and -independent vasodilatation are investigated in patients with t2dm (n =12) and healthy age-matched control subjects (n =12) with laser-doppler flowmetry during iontophoretic application of acetylcholine and sodium nitroprusside, respectively, before and after intra-arterial administration of the arginase inhibitor n-hydroxy-nor-l-arginine (0.1 mg/min) for 120 min.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus and microvascular dysfunction defined as microalbuminuria \> 3.0 mg/mmol or presence of retinopathy. exclusion criteria: * myocardial infarction or unstable angina within the last three months, * changed dose of any vasodilator drug during the preceding six weeks, * ongoing treatment with warfarin * concomitant disease that may have interfered with the possibility for the patients to comply with or complete the study protocol
effects of vitamin k on lower-extremity function in adults with osteoarthritis:

Conditions: Osteo Arthritis Knee

Summary: the overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin k supplementation on knee osteoarthritis progression and related functional decline. to address critical parameters required to design this larger rct, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee oa and low baseline vitamin k status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of mgp; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the osteoarthritis research society international (oarsi)-recommended performance-based tests of physical function in adults with low vitamin k status and mild to moderate knee osteoarthritis. we will also obtain preliminary data on the distribution of mgp genotype at two clinical sites for effect size generation.


Eligibility criteria:
inclusion criteria: * age ≥ 50 years * male or post-menopausal female (no menses in the last year) * plasma phylloquinone \<1.0 nmol/l * chronic knee discomfort based on affirmative response to the question "during the past 12 months, have you had pain, aching, or stiffness in or around your knee(s) on most days for at least one month?" * kellgren-lawrence (kl) grade 2-3 in at least one knee * ability to understand study procedures and to comply with them for the entire length of the study * ability to answer questions by phone * ability to swallow capsules exclusion criteria: * kl grade 4 in at least one knee * inability to walk * cognitive impairment (based on a montreal cognitive assessment test score ≤ 17) * widespread pain * malabsorption disorders (e.g. advance liver disease, stage 4 or 5 chronic renal disease, crohn's disease, celiac sprue) * serious medical conditions or impairments that, in the view of the investigator, would obstruct study participation * plan to permanently relocate from the greater boston, ma or chapel hill nc areas during the trial period * planned knee or hip arthroplasty during the study period * undergoing cancer treatment * \< 50 years old * circulating phylloquinone ≥ 1.0 nmol/l * warfarin (jantoven) use * use of other investigational drugs * use of herbal, botanical or vitamin k supplements * use of assistive walking devices

Keywords: osteoarthritis physical function nutrition